OCT 09, 2018 08:00 AM PDT

GMP Ancillary Materials for Cell and Gene Therapy Manufacturing: What to consider and when to make the switch

Speakers
  • Manager, Regulatory Affairs, Clinical and Compliance - Thermo Fisher Scientific
    Biography
      Kasey Kime has 10 years of Life Science quality and regulatory affairs experience. Her areas of expertise include raw material risk assessment for biopharmaceutical applications with a particular focus on cell and gene therapy customer and regulatory requirements. Kasey has been working at Thermo Fisher Regulatory Affairs for the last 7 years and is a core team member for new products developed for cell and gene therapy applications. Kasey holds a Bachelor's Degree in Medical Laboratory Science from Auckland University of Technology and holds post graduate degrees in science and quality systems.
    • Global Strategic Alliances Leader, Cell Therapy, Life Sciences Solutions Group - Thermo Fisher Scientific
      Biography
        Eric Roos has 30 years of experience in the development of biopharmaceuticals, cell therapy and tissue engineered products. He maintained a variety of responsibilities in the cell therapy industry supporting early phase development, process optimization, and clinical trial execution. His early controlled release, formulation, and biomaterials experience in transdermal, cytokine stimulated wound healing, and environmentally responsive hydrogels were leveraged to develop the encapsulated cell therapy and neural stem cell programs at CytoTherapeutics. His cell therapy experiences were then applied to develop commercial tissue engineering process technologies for wound healing products as leader of Process Development at Organogenesis. As Associate Director of Process Development at Bioheart Inc., he developed and tech transferred media and process improvements for the isolation and expansion of autologous myoblasts for clinical evaluation of a cardiac repair cell therapy. In his next roles as VP of Operations and Product/Process Development at Histogenics Corporation, he established the regulatory, process development, manufacturing, quality, and clinical systems for GMP production and clinical evaluation of an autologous tissue engineered cartilage repair product. Eric joined Thermo Fisher Scientific as part of Invitrogen in 2008 where his experiences were leveraged to identify global opportunities for platform development and adoption of industry enabling tools. He currently focuses on building Global Strategic Alliances and expanding the Cell & Gene Therapy Business Unit at Thermo Fisher Scientific. Eric holds a BSc. in Biochemistry from McGill University and has authored nine patents and a number of publications in the fields of drug delivery, biomaterials, cell therapy, and tissue engineering.

      Abstract:
      Register now for live event or to view the webinar on demand if you cannot make the live time.
       
      DATE: October 9, 2018
      TIME: 08:00am PDT, 11:00pm EDT
       
      Have you ever wondered what to consider when you are selecting ancillary materials for your cell therapy clinical research? This webinar will cover regulatory requirements for GMP ancillary materials and the importance of regulatory documentation and support to enable successful clinical translation. As you move through clinical trials toward commercialization you’ll need solutions that can scale with you to meet the clinical need. The second part of this session, will address aspects you should consider now such as scalability, consistency of supply and commercial use rights to help clear your path to commercial manufacturing in the future.
       
      Learning Objectives:
       
      • Regulatory requirements for GMP ancillary materials for cell and gene therapy
      • The importance of regulatory documentation and vendor support to enable successful clinical translation
      • How planning for commercial use considerations early can clear your path to the clinic and future commercial manufacturing
       
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